Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)

NCT ID: NCT02792543

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-09-30

Brief Summary

In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.

Conditions

Intestinal Failure With a Temporary High-output Double Enterostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

parenteral nutrition

Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.

Group Type: ACTIVE_COMPARATOR

parenteral nutrition

Intervention Type: DRUG

Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.

chyme reinfusion

Chyme reinfusion consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump.

Group Type: EXPERIMENTAL

Entéromate™

Intervention Type: DEVICE

Chyme reinfusion (the experimental treatment) consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump.

Interventions

Entéromate™

Chyme reinfusion (the experimental treatment) consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump.

Intervention Type: DEVICE

parenteral nutrition

Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.

Intervention Type: DRUG

Other Intervention Names

chyme reinfusion

Eligibility Criteria

Inclusion Criteria

• Aged over 18 years
• Temporary high-output double enterostomy (≥1500ml/24 hours)
• Total small bowel length ≥ 120 cm
• Downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion
• Oral feeding resumed for at least 5 days
• Parenteral nutrition or hydration required until the surgical reestablishment of digestive continuity
• Affiliation to an health insurance (general Social Security scheme or an equivalent scheme)
• No current or planned participation in another biomedical research
• Signature of an informed consent form

Exclusion Criteria

• Expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks
• Refusal by the patient to have a mixed texture diet,
• Chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity,
• Not drained intra-abdominal collection,
• Fever, uncontrolled infection, or infection treated for less than 72 hours,
• Shock of any cause,
• Creatinine clearance ≤ 60 ml/min
• Patients under guardianship.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Countries

France

Central Contacts

Cécile CHAMBRIER, MD

Role: CONTACT

cecile.chambrier@chu-lyon.fr

+33 4 26 73 26 59

Amélie ZELMAR

Role: CONTACT

amelie.zelmar@chu-lyon.fr

+33 4 72 11 51 15

Facility Contacts

Cécile CHAMBRIER, MD

Role: primary

cecile.chambrier@chu-lyon.fr

+ 33 4 26 73 26 59

Amélie ZELMAR

Role: backup

amelie.zelmar@chu-lyon.fr

+ 33 4 72 11 51 15

Other Identifiers

69HCL16_0098

Identifier Type: -

Identifier Source: org_study_id